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Race-Specific Drug Raises Ethical Questions

A Massachusetts-based pharmaceutical company announced this month that a two-drug combination pill could dramatically reduce deaths among black patients with heart disease. NitroMed released a study showing that blacks with heart failure who took Bidil lived significantly longer than those on a placebo. The results were significant since African Americans are more likely than white Americans to suffer from heart disease. But the concept of a race-based drug has sparked both interest and concern in the medical community.

If, as expected, the U.S. Food and Drug Administration approves Bidil for use by African Americans by the end of the year, it will be the first race-specific drug on the market. Dr. Jerry Avorn says it won’t be the last. Dr. Avorn, the author of Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs, predicts that NitroMed's findings -- and the profits the company might reap from them -- could prompt other drug manufacturers to re-analyze data from earlier studies, looking for racial anomalies.

"It may well be that this will create a fad," he said. "Companies will try and see whether there was a subgroup of this or that complexion that would be a marketing target on another drug based on another study."

The Association of Black Cardiologists cosponsored the research on Bidil. Association CEO Waine Kong looks forward to having more race-specific drugs on the market. Mr. Kong says American medicine is moving into a new era of personalized treatments. But he says that doesn't mean blacks are different than whites. "If the science shows that a treatment works," he said, "it doesn't matter what population you test it on. We need to trust the science. It doesn't mean it doesn't work with anyone else. But in this study, we used self-identified African American patients."

NitroMed created Bidil by combining two older drugs that had been developed by another company. Its specific benefit for black patients was largely unexpected. Dr. Gregg Bloche says the finding helped speed the drug through the FDA's approval process. Dr. Bloche, who teaches health law policy at Georgetown University, says he expects more pharmaceutical companies to become race conscious when developing new drugs, if only to get them to market sooner.

"NitroMed's predecessor was unable to get the drug approved as a medicine for everybody," he said. NitroMed "then did this trial which gives them powerful data that enables them to get the drug approved in all probability as a medicine for African Americans only. And now, having gotten to market that way, they are planning to, in fact, market the drug as a medicine for everybody."

NitroMed's lead author of the study says the company will work to identify other populations that can benefit from the drug.

Today most drugs in the United States are tested primarily on white men and, once approved, are prescribed at a physician's discretion for the rest of the population. Dr. Jerry Avorn says Bidil could represent the dawn of a new way of thinking, as pharmacologists begin to study how different races react to drugs. "There almost certainly are going to be important differences between blacks and whites and Asians and perhaps Hispanics," he said. "We know there are important gender differences between men and women, and people have not looked as carefully, perhaps, as they should have at racial or gender differences."

But, to some people, talk of a "black pill" raises the specter of racism and dredges up an old debate, long put to rest, that blacks are genetically or physically inferior to whites. Georgetown University's Gregg Bloche says that's not what the trials on Bidil indicated and he hopes that Americans understand that. "When this reaches the water cooler conversations and the talk show circuits, it's at risk of being translated into a story about blacks being fundamentally genetically or biologically different," he said. "And that's not what these investigators showed."

But some researchers fear that racial differences could become just a marketing ploy and that new, race-specific medicines will not necessarily benefit minority patients. "The idea of making good, effective and beneficial drugs that are more specific and have fewer side effects and are better drugs for a specific population is a wonderful thing," says Dr. Michael Grodin, Director of the Law, Medicine, Ethics and Human Rights Program at Boston University's School of Public Health. "The question is whether it's ethically justifiable if it's not going to actually benefit those people because it ultimately has to be affordable."

Cost will be an issue. By proving that Bidil works on African Americans, NitroMed was able to extend its patent to the year 2020, thereby keeping cheaper generic drugs off the market until then.